| Primary | Pain Intensity | Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible). Missing weekly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline pain intensity. | | Posted | | Mean | Standard Error | score on a scale | | Average over weeks 1-52 | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. | | OG003 | Medical Care (MC) | Medical care (MC): Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain. |
| | Units | Counts |
|---|
| Participants | - OG000305
- OG001201
- OG002193
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002.8± 0.1
- OG0013.0± 0.1
- OG0022.8± 0.1
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The null hypothesis here is that the means are equal across the 4 treatment groups. A significant p value indicates rejection of the null. | ANOVA | Adjusted for site, time period (pre-COVID, COVID, post-COVID), risk for chronicity (medium vs. high), and baseline pain intensity | 0.16 | Threshold for significance: 0.025 (0.05/2) | | | | | | | | | | | | | Other | Omnibus test for equality of means across the 4 treatment groups |
|
| Primary | Disability | Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities. Score ranges from 0 to 24 with higher values indicating more disability. Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline RMDQ. | | Posted | | Mean | Standard Error | score on a scale | | Average over months 1-12 | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Primary | Low Back Pain (LBP) That is Impactful | Measured by the LBP impact scale, which includes measures of pain intensity, pain interference, and physical function from the PROMIS-29 Profile v2.0. The scale ranges from 8 (least impact) to 50 (greatest impact). Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline LBP impact score. | | Posted | | Mean | Standard Error | score on a scale | | Average over months 10 -12 | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Recovery From Acute/Sub-acute Low Back Pain | Measured by the proportion of patients with scores of 0 on the 0-10 pain numeric rating scale (NRS) and a score of less than or equal to 2 on the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities. | | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. | | OG003 |
|
| Secondary | Low Back Pain Frequency - Percent of Days Over 12 Months | Participants report the number of days that low back pain has been a problem in the past 7 days for 52 weeks. This measure is the percent of days that low back pain has been a problem. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity. | Only participants with at least 35 weeks of follow-up between weeks 1 and 52 are included in the analysis. | Posted | | Mean | 95% Confidence Interval | Percent of days | | Weeks 1-52 | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | |
|
| Secondary | Number of Participants Who Received Care For Low Back Pain | Includes provider visits, emergency department visits, diagnostic imaging scans, hospitalizations, injections and surgical procedures. This is a binary indicator of any care from providers outside the study for low back pain. | Only participants with at least 8 months of follow-up between months 1 and 12 on this outcome are included in the analysis. | Posted | | Count of Participants | | Participants | | Months 1-12 | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Medication Use - Percent of Months 4-12 | Over the counter and prescription medication use for low back pain. Since the MC arm intervention includes medications, only months 4-12 (i.e. after the intervention) are considered for this outcome. The measure is the percent of months 4-12 in which medication was used for low back pain. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity. | Only participants with at least 6 months of follow-up between months 4 and 12 are included in the analysis. | Posted | | Mean | 95% Confidence Interval | Percent of months 4-12 | | Months 4-12 | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT |
|
| Secondary | Bothered by Low Back Pain at Work - Percent of Months | Participants indicated in monthly follow-ups if they were bothered by low back pain over the last month. This measure is the percent of months that participants were bothered by low back pain at work. Mean and confidence intervals are estimated using marginal standardization and bootstrapping. Adjustment for site, time period, and risk for chronicity. | Only participants with at least 8 months of follow-up between months 1 and 12 are included in the analysis. | Posted | | Mean | 95% Confidence Interval | Percent of months | | Months 1-12 | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | |
|
| Secondary | Global Improvement | Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered ) | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | score on a scale | | 2 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Global Improvement | Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered ) | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | score on a scale | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Global Improvement | Measured using a 9-point scale: 0 (vastly worse) to 8 (completely recovered ) | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Patient Satisfaction With Treatment | Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied) | The counts above are for participants that completed the satisfaction question at the 2-month time point. The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | score on a scale | | 2 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT |
|
| Secondary | Patient Satisfaction With Treatment | Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied) | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | score on a scale | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Patient Satisfaction With Treatment | Measured using a 7-point Likert scale: 0 (completely dissatisfied) to 6 (completely satisfied) | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Chronic Low Back Pain (LBP) | Measured by the proportion of patients in each group meeting the definition by the NIH Task Force on Research Standards for Chronic LBP (i.e., ongoing LBP on ≥50% of days over past 6 months). | | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. | | OG003 | Medical Care (MC) | |
|
| Secondary | Chronic Low Back Pain (LBP) | Measured by the proportion of patients in each group meeting the definition by the NIH Task Force on Research Standards for Chronic LBP (i.e., ongoing LBP on ≥50% of days over past 6 months). | | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. | | OG003 | Medical Care (MC) | |
|
| Secondary | Number of Participants Who Reported Chronic Interference With Daily Activities | Assessed using "how often has low back pain interfered with your ability to do regular activities over the past 6 months?" on a 3-item scale (less than half the days in the past 6 months, at least half the days in the past 6 months, every day or nearly every day in the past 6 months). Here we dichotomize to "at least half the days in the past 6 months" or more. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
|
| Secondary | Number of Participants Who Reported Chronic Interference With Daily Activities | Assessed using "how often has low back pain interfered with your ability to do regular activities over the past 6 months?" on a 3-item scale (less than half the days in the past 6 months, at least half the days in the past 6 months, every day or nearly every day in the past 6 months). Here we dichotomize to "at least half the days in the past 6 months" or more. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
|
| Secondary | Timed Up and Go Test | Measured by a blinded examiner, in seconds, the time taken by a person to stand up, walk a distance of 10 feet, turn, walk back to the chair and sit down again. | Unlike outcomes collected via surveys, this outcome required an in-person meeting or teleconference. It was frequently difficult to schedule within the outcome window and thus has lower follow-up than survey outcomes. | Posted | | Mean | Standard Deviation | seconds | | 2 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Sit-to-stand | Measured by a blinded examiner, in seconds, the amount of time a person requires to stand up and sit down from a chair 5 times without using their arms | Unlike outcomes collected via surveys, this outcome required an in-person meeting or teleconference. It was frequently difficult to schedule within the outcome window and thus has lower follow-up than survey outcomes. Measure was not collected in the UG3 phase of the study (November 2018 through April 2019). | Posted | | Mean | Standard Deviation | seconds | | 2 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | The Sock Test | Measured by a blinded examiner on a scale from 0-3, with 0 being can easily grab the toes with the fingertips of both hands and 3 being can hardly, if at all, reach as far as to the malleoli. Each leg is scored separately with the greater leg score serving as the overall score. | Unlike outcomes collected via surveys, this outcome required an in-person meeting or teleconference. It was frequently difficult to schedule within the outcome window and thus has lower follow-up than survey outcomes. | Posted | | Count of Participants | | Participants | | 2 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | |
|
| Secondary | Visual Trajectory for Pain | Assessed using 8 different diagrams describing back pain change over the last 12 months | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | Supported self-management / spinal manipulation therapy (SSM/SMT): Combination treatment. |
|
| Secondary | Quebec Task Force | Measured by a blinded examiner who will classify the participant's spinal disorder as 0) no pain; 1) pain without radiation; 2) pain with radiation to the proximal extremity; 3) pain with radiation to the distal extremity; 4) pain with radiation to the extremity and neurologic signs. | Unlike outcomes collected via surveys, this outcome required an in-person meeting or teleconference. It was frequently difficult to schedule within the outcome window and thus has lower follow-up than survey outcomes. | Posted | | Count of Participants | | Participants | | 2 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. | | OG002 | Combined SSM/SMT | |
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression | The PROMIS depression scale consists of 4 questions related to depression over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 41.0 - 79.3. Higher scores indicate greater depression. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | T-Score | | Baseline and 2, 6, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | The PROMIS physical function scale consists of 4 questions about ability to perform tasks of daily living. The raw score is converted to the T-Score that is reported here. The range of possible scores is 22.6 - 57.0. Higher scores indicate greater physical function. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | T-Score | | Baseline and 2, 6, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety | The PROMIS anxiety scale consists of 4 questions related to anxiety over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 40.3 - 81.4. Higher scores indicate greater anxiety. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | T-Score | | Baseline and 2, 6, and 12 months | | | | ID | Title | Description |
|---|
| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
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| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue | The PROMIS fatigue scale consists of 4 questions related to fatigue over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 33.7 - 75.8. Higher scores indicate greater fatigue. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | T-Score | | Baseline and 2, 6, and 12 months | | | | ID | Title | Description |
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| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
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| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance | The PROMIS sleep disturbance scale consists of 4 questions related to sleep disturbance over the past 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 32.0 - 73.3. Higher scores indicate greater sleep disturbance. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | T-Score | | Baseline and 2, 6, and 12 months | | | | ID | Title | Description |
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| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
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| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Participation | The PROMIS participation scale consists of 4 questions related to participation in social activities. The raw score is converted to the T-Score that is reported here. The range of possible scores is 27.5 - 64.2. Higher scores indicate greater ability to participate in social activities. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | T-Score | | Baseline and 2, 6, and 12 months | | | | ID | Title | Description |
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| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
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| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference | The PROMIS participation scale consists of 4 questions related to pain interference in the last 7 days. The raw score is converted to the T-Score that is reported here. The range of possible scores is 41.6 - 75.6. Higher scores indicate greater pain interference. A score of 50 represents the average score in a general US reference population and 10 is the standard deviation. | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts for each time point here may differ somewhat from the Participant Flow tables. | Posted | | Mean | Standard Deviation | T-Score | | Baseline and 2, 6, and 12 months | | | | ID | Title | Description |
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| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
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| Secondary | STarT Back Risk Classification | The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4). | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts may differ somewhat from the Participant Flow tables. | Posted | | Count of Participants | | Participants | | 2 months | | | | ID | Title | Description |
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| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
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| Secondary | STarT Back Risk Classification | The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4). | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts may differ somewhat from the Participant Flow tables. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
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| Secondary | STarT Back Risk Classification | The STarT Back Screening Tool is a 9-item questionnaire used to identify prognostic risk factors in patients with low back pain. It assesses physical and psychosocial factors, including referred pain, disability, fear-avoidance, anxiety, and depression. Scores are totaled (0-9) and a psychosocial subscale score (items 5-9, range 0-5) is calculated. Patients are classified as: low risk (total ≤3), medium risk (total ≥4 and psychosocial subscale ≤3), or high risk (total ≥4 and psychosocial subscale ≥4). | The Participant Flow tables show counts of completed follow-up defined by completion of the Roland-Morris Disability Questionnaire (RMDQ). There are some participants who completed the RMDQ but not this measure and vice versa. Thus the analysis counts may differ somewhat from the Participant Flow tables. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Supported Self-Management (SSM) | Supported Self-Management (SSM): Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping. | | OG001 | Spinal Manipulation Therapy (SMT) | Spinal manipulation therapy (SMT): Addresses the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine. |
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| Other Pre-specified | Self-efficacy | Using a 10-100 numerical rating scale (10=very uncertain, 100 = very certain), self-efficacy is measured with the 22-item Chronic Pain Self-Efficacy Scale adapted for acute/sub-acute pain. This is a psychosocial mediating measure. | | Not Posted | | | | | | Baseline, 2, 6, 12 months | | Participants | | | | |
| Other Pre-specified | Catastrophizing | Measured using the 13-item Pain Catastrophizing Scale; it uses a 5-item point scale (0=not at all, 4 all the time). This is a psychosocial mediating measure. | | Not Posted | | | | | | Baseline, 2, 6, 12 months | | Participants | | | | |
| Other Pre-specified | Kinesiophobia | Measured using the 11-item Tampa Scale for Kinesiophobia demonstrated to have internal consistency, responsiveness and validity similar to the original 17-item instrument. A four-item scale is used (strongly disagree to strongly agree). This is a psychosocial mediating measure. | | Not Posted | | | | | | Baseline, 2, 6, 12 months | | Participants | | | | |
| Other Pre-specified | Coping | Measured using an adapted version of the 28-item Brief Coping Orientation to Problems Experienced (COPE) instrument on a 4 point scale (I haven't been doing this at all to I've been doing this a lot). This is a psychosocial mediating measure. | | Not Posted | | | | | | Baseline, 2, 6, 12 months | | Participants | | | | |